FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD

FDA Approves Updated Novavax COVID-19 Vaccine

FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD / Tada Images - stock.adobe.com

The FDA granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older, the company announced in a release. Novavax said the vaccine will be available in thousands of pharmacies and grocers across the United States after batches are released by the Center for Biologics Evaluation and Research.

The protein-based vaccine, called NVX-CoV2705, is an updated 2024-2025 formula that includes a monovalent component corresponding to the Omicron variant JN.1 strain. The EUA was based on non-clinical data that showed the vaccine provides cross-reactivity against JN.1 and lineage viruses, including numerous variants that are currently circulating.

FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

The FDA granted clearance to the digital therapeutic DaylightRX for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older, Big Health announced. The therapy is the first digital treatment approved to treat GAD in the United States.

DaylightRX is a digital formulation of cognitive behavioral therapy (CBT) and includes lessons that teach patients different evidence-based techniques to help reduce chronic worry and anxiety, including applied relaxation, stimulus control, cognitive restructuring, and exposure therapy. The therapy, which is available by prescription only, was developed based on Big Health’s existing digital care program Daylight.

FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D

Embecta received 510(k) clearance from the FDA for its proprietary disposable insulin delivery system indicated for adults with type 1 (T1D) and type 2 diabetes (T2D) and informed by feedback from people with T2D.

Whereas some on-market patch pumps don't hold enough insulin to sustain users’ needs for extended use, embecta’s wearable, fully disposable patch pump and 300-unit (300u) reservoir provide adjustable basal and bolus insulin for up to 3 days. This expanded reservoir better accommodates individuals with higher daily insulin needs, commonly seen in T2D, as well as those who are interested in transitioning from multiple daily injections (MDI) to pump therapy.

FDA Authorizes IND For Phase 2 Clinical Trial Evaluating Treatment for Post–COVID-19 Condition

The FDA authorized BioVie’s investigational new drug application for the evaluation of bezisterim to treat neurological symptoms associated with post-COVID-19 condition. In a phase 2, randomized, placebo-controlled, multicenter clinical trial, investigators will evaluate the safety and tolerability of bezisterim over 3 months of treatment in a cohort of 200 patients, as well as the drug’s “potential ability to reduce the neurocognitive symptoms associated with long COVID.”

Bezisterim (NE3107) acts on fundamental inflammatory signaling pathways. It selectively inhibits the inflammatory extracellular signal-regulated kinase (ERK) pathway that “reduces neuroinflammation by inhibiting inflammation-driven insulin resistance and major pathological inflammatory cascades.” The drug is orally bioavailable and blood-brain-barrier permeable, is not immunosuppressive, and has a low risk of drug-drug interactions. Bezisterim modulates the activation of NFkB, which modulates inflammation.

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